Clinical Research Associate

☑ Основной блок:

Опыт работы: не требуется.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 18445655 добавлено в базу данных: Воскресенье, 19 января 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "ООО Ново Нордиск":

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☑ Подробности о вакантном месте:

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.

Headquartered in Denmark, Novo Nordisk employs over 43,000 people in 80 countries, and markets its products in more than 170 countries.

Our history in Russia can be traced to 1924 and with the recently (2018) completed expansion of our greenfield and wholly owned modern insulin manufacturing facility in Kaluga now we are proud more than ever of our commitment to Changing Diabetes® for the 10 million people with diabetes in Russia.

We are launching new products, making them more accessible to patients, and we also see ambitious government healthcare plans (National Projects) that are aligned with our own long-term commitments through Changing Diabetes® and Changing Obesity®.

For the future, we have set ambitious plan to deliver strong growth, which builds on our success and emphasizes critical components of performance: leadership and outperforming the competition. It is therefore a pleasure to announce the creation of new frontline focused positions, to increase our share of voice and coverage.

The position

As the Clinical Research Associate you will be the primary point of contact between site staff and Novo Nordisk, you will act as an ambassador for the company. As the Jr. CRA you will be responsible for monitoring of the study at sites in compliance with local regulations, ICH-GCP, NN procedures and protocol requirements to ensure data quality and study subject protection, as well as for recruitment at site level. At this role, you will deliver results that have a direct impact on the successful completion of the clinical program.

Main responsibilities also include:

• Prepare trial documents for submission to Regulatory Authorities;
• Perform sites feasibility and investigators’ selection;
• Communicate with sites for ensuring adequate enrolment rate;
• Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.);
• Support audit and inspections at sites as applicable;
• Prepare and submit Monitoring Visit Reports within defined timelines;
• Maintain and update study related documentation from CRA's area responsibility;
• Manage and complete reporting of Serious Adverse Events happened within Clinical Trials on site;
• Provide study related training for Investigators on the routing practice;
• Proactive use of electronic data capture system (EDC) for preparation and conduct of site visits as well as source data verification in collaboration with data management.

Qualifications

• You hold University degree (life science or medical/pharmaceutical preferred).
• Experience in on-site monitoring is preferred, however, other relevant experiences and skills may be considered when considering the candidate’s eligibility.
• Your experience in local study management will be a strong advantage.
• Knowledge of GCP and local laws and regulations for clinical trials is preffered.
• Computer literacy (e.g. EDC, IMPACT, MS Office, etc.).
• Excellent verbal and written communication skills in English.
• Willing and able to travel.

On a personal level, you have good at planning, coordinating & prioritizing activities in order to ensure optimal use of resources in the department, as well as good negotiation, communication & collaboration skills.

You are able to relate to people in a diverse & international environment, to handle numerous tasks simultaneously.

You have analytical type of thinking, attention to details and easy learning skills.

You demonstrate quick problem-solving capability and ability to work in stressful situations.

You are also able to be initiative, innovative and proactive, to work independently and as a part of the team

About the department

Clinical department of Novo Nordisk in Russia conducting clinical trials II-IV phases according to Good Clinical Practice and local regulatory requirements.

Working at Novo Nordisk

At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Help us bring quality to life. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Are you ready to make a difference?

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

☑ О компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; .

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